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7 Common Mistakes That Can Delay Your FDA 510(k) Clearance - Featured Image

7 Common Mistakes That Can Delay Your FDA 510(k) Clearance

  The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical de...
Technical File vs. 510(k) vs. Design History File: What Medical Device Developer Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developer Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device - Featured Image

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...
The Ultimate Guide to Preparing Your FDA 510(k) Submission - Featured Image

The Ultimate Guide to Preparing Your FDA 510(k) Submission

What's this guide all about anyways? Feeling a little lost as you start to compile your first 510(k)...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the r...
How Design Controls Apply to a 510(k) - Featured Image

How Design Controls Apply to a 510(k)

If you are developing a medical device for the U.S. market, you first need to determine how your dev...
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues - Featured Image

How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues

In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascu...
5 Tips to Help Your FDA 510(k) Submission (checklist included) - Featured Image

5 Tips to Help Your FDA 510(k) Submission (checklist included)

If you are developing a medical device in the United States, there is a good chance your path to mar...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.